JIM LEHRER: The government today began making available the anthrax vaccine to those exposed to the inhaled form of the disease. Here now is Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health. He’s the federal government’s leading infectious disease expert. Dr. Fauci, welcome.

DR. ANTHONY FAUCI: Thank you.

JIM LEHRER: First, who is eligible now to get the vaccine?

DR. ANTHONY FAUCI: Any of the individuals who were exposed to anthrax during the anthrax incident when we had the bio-terrorism exposures who had been on antibiotics for protection for what we call prophylaxis against their developing anthrax, have coming now or have already arrived at the end of their antibiotic period of time.

So they’re being offered the vaccine together with a continuation for a period of time of the antibiotics, in order to– if they make their choice, because this is not something that we have a lot of information about, so that’s why we use the word making it available for individuals in their free and open consent that that’s what they would want to do, if they feel they want to go the extra mile to make sure that they do not come down with anthrax.

JIM LEHRER: How many people are we talking about?

DR. ANTHONY FAUCI: The universe of potential people is about 9,000. If you talk about the people who were exposed clearly to a situation where they very well may have inhaled anthrax as opposed to somebody just maybe walking by the place, indirectly involved, that number is about 3,000 individuals. And within that group there clearly going to be people who are going to elect to feel that that’s just not what they want to do, so it’s about 3,000 at the highest I would imagine.

JIM LEHRER: Is there going to be government policy to get as many as these people vaccinated as possible or to hold down the number, or does it matter to you?

DR. ANTHONY FAUCI: Well, actually, that’s a very good question, Jim. There’s not going to be a policy one way or the other, and I think that’s important to emphasize so that people really understand what’s going on right now.

Since the scientific data, particularly in animal models, do not indicate one way or the other whether or not that this is going to be helpful, in fact the data in monkeys indicate that there really was no difference between monkeys who received the antibiotics plus the vaccine versus the antibiotics alone, there is a theoretical possibility that there may be helpful in the context of the fact that we know from an animal model that even weeks and weeks after exposure of an animal there are some residual stores — spores, excuse me, in the respiratory tree. And for that reason, given that hypothetical context, the vaccine is made available.

So it isn’t like saying we’re recommending you do this and if you don’t do it you’re putting yourself at danger. It’s a question of an open choice.

JIM LEHRER: But to use your numbers, if all 9,000 of these people want the vaccine, they can have it, right?

JIM LEHRER: That’s a point but it’s kind of a strange point, isn’t it, Doctor? I mean to offer these things and not care if anybody gets it?

DR. ANTHONY FAUCI: I don’t want to use the word uncare, because that seems insensitive to the feelings of people. What we do care about – and this is important — that people are given the free and open choice to make a decision based on what they feel is the level of risk that they are willing to take — one risk of the vaccine itself, as well as the perceived hypothetical and theoretical consideration that maybe the vaccine might help you out, and since there are toxicities associated with the vaccine, and importantly the vaccine has never been used in a context like this, that’s the reason why you need informed consent and you need a decision on the part of the individual themselves.

JIM LEHRER: Now, what constitutes informed consent? What is it that these people should know about this vaccine in terms of its risks et cetera before they agree to do it?

DR. ANTHONY FAUCI: In essence it’s a little bit more detailed than what I just told you over the past minute or so. What are the data that indicate or not that this would be helpful, what is the vaccine being used for, pointing out that it has never been used in this situation before, what are the toxicities of the vaccines, what are the pros and cons, you read it, you ask questions, I’m sure they’re going to have questions. You try as best you can to answer the questions. And then you take it or not.

JIM LEHRER: So what’s the number one potential risk of taking this vaccine?

DR. ANTHONY FAUCI: The number one potential risk is the risk associated with taking any vaccine — namely toxic side effects.

JIM LEHRER: It’s given just like any vaccine, right, with a needle in the arm?

DR. ANTHONY FAUCI: Yes, correct. So that’s the risk. Now as you know, there have been perceptions, the history of this vaccine, of people feeling that they got the vaccine and that there were side effects associated with that, when people examined them over a large number of people, there’s some, quote, controversy about that, but there’s the general feeling that it’s a reasonably safe vaccine.

But there are toxicities. And whenever you give anyone a drug or a vaccine, there is a finite risk there, which is the reason why since you’re not sure that there is going to be any benefit from it, that’s a very important ethical consideration that if there’s a risk to what you’re going to do, and there’s not a definite potential benefit of it that has been proven as a benefit, you’ve got to be very careful that you don’t strongly urge something as opposed to making it available with the informed consent of the individual.

JIM LEHRER: If it’s not, there’s no certainty that this is going to help, how did we get to this situation where it is being offered to people?

DR. ANTHONY FAUCI: The situation is that a feeling and an attempt on the part of Secretary Thompson, the Department, and even the administration in general, about making sure of going the extra mile that every possible conceivable benefit, even though it has not been proven, is at least going to be made available to individuals, at least be made available to them. So that we can’t say you know we could have done something, but we didn’t make it available to them.

JIM LEHRER: Is a system in place to track the reaction of people who do take this vaccine?

DR. ANTHONY FAUCI: Yes. Absolutely. Because you’re doing it again in what we call an investigational new drug program, which means unlike going to the store and buying a medicine and taking it, and you don’t get any follow, when you do it under a program that’s under the umbrella of an investigational new drug, not only do you have informed consent, but you’ve got to come back and report, do you have any toxicities; you have to come back for the second and third installment of the vaccine. So it is a rather continuous following of the individuals.

JIM LEHRER: What’s your level of confidence about the cleanliness, the quality of the vaccine that is available?

DR. ANTHONY FAUCI: Well, the FDA has been following this, obviously. I’m not the FDA, but I can tell you exactly what they said. The vaccine lot that will be given to these individuals, although it hasn’t been approved yet for licensure, the FDA says that it is of the quality that has the potential to be approved once the final inspection of the plant that made it. So it is almost certain that it’s going to get approved, it’s in the category that the FDA feels comfortable with it.

JIM LEHRER: Speaking of comfortable, unfair question. If you went confronted with this, with all that you know, would you take this if you felt you had been exposed?

DR. ANTHONY FAUCI: You know why I’m not going to answer that, Jim, because it will be a, it will be a sound bite. But I can tell you, and I think this maybe will inform others who are thinking about it, it depends on what level of risk you’re interested in taking, because there are some individuals, and I’ve spoken to a lot of people over the past several weeks and even throughout my medical career, who feel that even if there’s a slight chance of helping, they want to go the extra mile and they’re not worried about the toxicities of a vaccine.

There are other people when you say the vaccine might have some toxicity, they say I don’t want any part of that, I’ll take my chances and if I feel like I’m going to get sick, I’ll go straight to my doctor and have them give me antibiotics, which I know are going to be helpful for me. And there are a lot of people on either side of that fence.

JIM LEHRER: I know you’re not an investigator, but how close are they to finding out where all this anthrax came from?

DR. ANTHONY FAUCI: Well, from what we read in the newspapers, and I read the same papers that you do, it looks like understanding the quality and the kind of spores that have been involved, that it looks like that if they’re not getting very close they’re certainly moving in towards getting a feel for where it might have come from. So I’m confident that sooner or later we’re going to find out what’s going on.

JIM LEHRER: As an expert, do you understand why it’s taken so long?

DR. ANTHONY FAUCI: Why it’s taken so long?

JIM LEHRER: To find out where it came from.

DR. ANTHONY FAUCI: Well, I’m not a law enforcement expert.

JIM LEHRER: But I mean on infectious diseases and all this sort of thing.

DR. ANTHONY FAUCI: I’m not –

JIM LEHRER: I mean, you have sympathy for why it’s so difficult to trace –

DR. ANTHONY FAUCI: Oh, of course. I am not at all critical of our law enforcement and our intelligence individuals. I think that they are doing a terrific job. To say okay, where is the person who did it, you have an undetectable type of an agent, this weapon that they’re using, and an unknown assailant, that’s a tough thing for them to be challenged with. So I’m very empathetic with our law enforcement officials.

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